Review by Joseph Ross – 07/11/2019 – 10:09am

Data Request Number: 2019-3943 Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

This is a useful secondary analysis of the REACH trial, determining whether serum infliximab concentration is associated with improved outcomes among pediatric patients with moderate-to-severe Crohn’s disease. My only concern is whether serum infliximab concentrations were collected at weeks 2, 6 and 10, as needed by the investigators. This should be confirmed with the clinical trial team at Janssen.

Recommendation for this data request: Approve